MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC METRX II; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 9560524

Device Problems Unstable (1667); Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis #(b)(4): in the inspection at the time of receipt, the deformation of the screw thread of the handle screw was confirmed.We also confirmed a crack in the bearing.We replaced parts, disassembled and cleaned, lubricated, and adjusted.We conducted the final operation test and attached a repair / inspection completion sticker.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health care facility via a manufacturer representative regarding a flex arm used in micro endoscopic discectomy.Pre op diagnosis was lumbar disc hernia it was reported that the device cannot be fixed and wobbles.The event occurred during procedure.No patient symptoms/complications as a result of this event.The product did not come in contact with the patient.

• Brand Name: METRX II
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 11312392
• MDR Text Key: 234215080
• Report Number: 1030489-2021-00177
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9560524
• Device Catalogue Number: 9560524
• Device Lot Number: MY14C001R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Date Manufacturer Received: 01/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1